摘要
目的通过对新型雄激素受体拮抗剂药物警戒信号进行挖掘分析,探讨三药(恩扎卢胺、阿帕他胺、达罗他胺)潜在的神经系统药物不良反应信号,为临床安全合理用药提供参考。方法通过挖掘美国食药监督管理局不良反应中心数据库中有关恩扎卢胺、阿帕他胺、达罗他胺的相关数据,采用比例失衡法检测获得的药物警戒信号。结果分别提取到52134例以三种拮抗剂为首要怀疑药物的不良反应事件报告,共检测出2378个警戒信号,其中,涉及神经系统信号为40个,恩扎卢胺、阿帕他胺、达罗他胺分别为:23、18、9个,并且15个信号未被药品说明书收录。结论新发现的不良反应信号能够给予临床一定的警示作用。在出现未知不良反应时,能够及时给予对症治疗。在提高病人的生存率的同时,改善其生活质量。
OBJECTIVE To explore the potential neurological adverse drug reaction signals of the three novel Androgen Receptor Antagonists,Enzalutamide,Apalutamide and Darolutamide,by mining and analyzing the pharmacovigilance signals,and to provide references for the safe and rational use of these drugs in clinical practice.METHODS The relevant data of the three antagonists in the USA Food and Drug Administration Adverse E-vent Reporting System database were mined,and the pharmacovigilance signals were detected by the proportional reporting ratio method.RESULTS A total of 52,134 adverse event reports with the three antagonists as the primary suspected drugs were extracted,and 2,378 pharmacovigilance signals were detected,among which 40 were related to the nervous system.The numbers of signals for enzalutamide,apalutamide and darolutamide were 23,18 and 9,respectively.Moreover,15 signals were not included in the drug instructions.CONCLUSION The newly discovered adverse reaction signals can provide certain warnings for clinical practice.When unknown adverse reactions occur,timely symptomatic treatment can be given.This can improve the survival rate of patients and their quality of life.
作者
李树荣
林拯
LI Shu-rong;LIN Zheng(Department of Pharmacy,Quanzhou Hospital of Traditional Chinese Medicine,Quanzhou 362000,China;Department of Pharmacy,The First Hospital of Quanzhou,Quanzhou 362000,China)
出处
《海峡药学》
2025年第12期143-147,共5页
Strait Pharmaceutical Journal
